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OpenTrials
Completed

NCT Number: NCT02001740

An RCT in Treatment of Adhesive Capsulitis Arthrographic Joint Distention With Local Anesthetic Alone

Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to affect 25% of the general population. Many forms of treatment have been advocated for frozen shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid, manipulation under anesthetic and arthroscopic releases. There is no general agreement in favour of one form of treatment, and the response to a particular treatment varies in different series. A few randomized controlled trials appear in the literature. Most of these showed improvements with steroid use, but the results were not always statistically significant. One randomized control trial reported superior results in favor of arthrographic joint distension with steroid compared to a saline placebo. To our knowledge there have been no other similar randomized trials to support these results. The objective of this study is to determine if arthrographic distension of the shoulder joint with steriods is an effective treatment modality for adhesive capsulitis as compared to injection with local anesthetic and contrast alone. The study design is a placebo-controlled, double blind clinical trial where participants will undergo distension arthrogram of the shoulder and be randomized to receive either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and contrast alone.

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kingston General and Hotel Dieu Hospitals

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range 19-70
  • Female and male
  • Ability to understand and give consent
  • Diagnosis of adhesive capsulitis (frozen shoulder) pain and stiffness for at least 3 months.

Exclusion criteria

  • • Frozen shoulder secondary to trauma
  • Previous surgery on the affected shoulder
  • Age less than 19 or greater than 70
  • Systemic inflammatory joint disease such as Rheumatoid Arthritis
  • Radiographic evidence of osteoarthritis of the shoulder
  • Allergy to contrast material
  • Pregnant or breastfeeding women

Treatment and study plan

Triamcinalone (steroid) and lidocaine

Drug

receive once

Lidocaine

Other

receive once

Primary outcomes

  1. functional outcomes as determined by the SPADI

    Time frame: change in baseline at 1 year.

Secondary outcomes

  1. passive range of motion

    Time frame: baseline, 3 and 6 and 12 week post injection.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

Treatment of Adhesive Capsulitis: A Randomized Placebo-Controlled Trial Comparing Arthrographic Joint Distention With Steroid and Local Anesthetic Versus Arthrographic Joint Distention With Local Anesthetic Alone

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2013
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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